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Double Blind Study of Hydroxyzine, Promethazine, Secobarbital, and a Placebo for Pi~Eanaesthetic Medicatio N ~

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Double Blind Study of Hydroxyzine, Promethazine, Secobarbital, and a Placebo for Pi~Eanaesthetic Medicatio N ~ DOUBLE BLIND STUDY OF HYDROXYZINE, PROMETHAZINE, SECOBARBITAL, AND A PLACEBO FOR PI~EANAESTHETIC MEDICATIO N ~ ALLEN B DOBKIN, M D, ~SHAN MALIK, M D., AND ~AC~3r~S Is~r~, M D H'evaoxYzmE (Atarax@, Vlstarll@) has been under ehmcal trial to determine its efllcaey for pre-anaesthetae medacaUon on the bas.~ of its purported ne~oseda~jve, antihistaminic, anhspasmodle, anta-emet~c, and anaesthellc potentaatmg proper- ties ~4 Laboratory studies have shown that the intravenous mleetmn of hydr0xy- zme causes a transmnt fall m blood pressure, an increase m coronary blood flow, and suppressmn of epinephrine-reduced ventrmula~l arr]hythmms 7 The pmtec- tare effect of hydroxyzme against arrhythmms is unrehable s In ehmeal tests, the therapeutic sedative dose has ~nrtually no antasml0gogue effect, 9 nor doe~s It chsturb the blood pressure even when circulatory stress of 60-degree head-up tilt is used t0 No undesirable side effects have been reported chmeally Promethazme (Phenergan@) has been used widely for pre-anaesthetm medaca- tlon dmmg the past ten years, ~x-~ paracularly when it as desirable to provade an antflustammm effect a7.~s It ~s a potent sedative, as deltermmed by the potentmi~on of ttnopental anaesthesm, s as a powerful antlslalogogue on account of its marked antxchohnerglc properties, ~9 ~0 and it has a mmmaal effect on the ctrculatory response to hlt 2~ The only drawback to ~ts routine u~e as the frequent complaint by patients of a "twltchy" feehng, whmh appears to be a common effeci of phenottnazme denvataves 2z 2~ Secobarbltal ~s a short-acting hypnotxc sedattve that has been used w~dely' for pre-anaesthet~e medmataon for many years It ~s recogmzed to be effective and has va-tually no undesirable effects, except that oceasmnally an elderly patient becomes confused during the half-asleep state that as reduced, whmh increases the ala~zn ff the patient as m an unfamflmr env~rorltment Tlh~s response as not uncommon w~th most of the barbiturate sedattves ~z Th~s report describes a double-bhnd study m whaeh hydroxyzme, secobarb~tal and a placebo (coded unlmowns) were compared w~th prornethazme (coded, but known) for pre-anaesthetac medmataon ~J[ETHODS Four hundred identical capsules were prepared of rwhlch 100 contained 50 mg ~From the Department of Anesthesiology, State Umve~slty Hospital, State Umvelrs~ty of New York, Upstate Medical Center, Syracuse, New York, 13910 499 Can Anaes Soe J, vol 12, no 5, September, 1965 500 CANADIANAI~,U~ST~!TS' SOCmT~ JOURNAL hydroxyzme (Vxstanl| 100 contained 50 mg promethazme t~Phenergan| 100 contained 100 mg secobarbital (Seconal| and 100 contained a placebo, lactose, and 2-ml brown ampoules were prepared, 100 containing 25 mg/ml hydroxyzme, 100 containing 50 mg/ml secobarbltal, and 100 containing a placebo, sahne Promethazme was prov:tded m cartridges containing 25 mg and 50 mg A random-number table was used to alsslgn the three drugs and the placebo to a hst of 400 consecutwe numbers Enwdopes contammg a capsule for evening oral administration, and an ampoule of the same compound (or cartridge of promethazme) for morning mtramusculal admlmstratmn were labelled with the assigned number and sealed The envelopes with the drugs were placed an the hospltal pharmacy and were req~alsltmned m numenca]l sequence A sealed copy of the drug code was kept by the pharmacist until the study was completed and aH data were tabulated Each day following pre-anaesthetm roull~ds, adult patmnts who were scheduled for a major electwe operation, who were ludged to be fit for the contemplated surgma| procedure, and for whom a genera| anaesthetm was considered appro- prmte, were assigned a consecutwe coded drug number Those patmnts who were to have mtracramal or cardmpu]m~l~raary procedures, and tllose who were to have short operatmns, were excluded ~lrom the study A capsule of the coded drug was always prescrxbed for oral admmlstratmn at the time of retmng, and a I volume of the drug not exceeding 2 ml Was ordered for mtramulscular injection one hour before the time os operatmn, along with 0 3 to 0 4 mg scopo|amme The volume of the coded drug pxescnbed was based upon the size, physique, and mental state of the patmnt Although all tlhe preparatmns used were an numbered envelopes, the nurse who administered pIlomethazme m each case would be able to identify thxs drug because it was slupphed m a cartridge instead of an ampoule, so on~ly three cff the four prepmatlons were considered as unknowns For each case that was studmd, a qtxeStlonnalre (see Fig 1) was completed by a graduate nurse who was trained s this study and assigned to it full-time She abstracted mformatmn from the patient's chart pre-operatlveiy, asked the patient direct questxons ~mmedmtely prmr to mductmn of anaesthesm, and questioned the anaesthesmlogast xmrned,ately following mductmn of anaesthesm All anaesthetms were superwLsed dlrectly by the authors, who used a uniform reduction procedure (gaHamme with thmpental ), and maintenance of anaesthesm was carrmd out m most cases w~th either mtrous ox~de-halothane c,r mtrous oxade-- methoxyflurane and controlled resplratmn m a non-rebreathmg system Post~ operatively, the anaesthetm chart and th e recovery room record were abstracted by the same nurse~ she wsxted the patmnt 24 hours postoperatively to obtain pertinent ~rfformatxon from the chart and to question the patient further, then the protocol was checked ~or completeness by one ot~ the authors At the conc]lusxon of the study, all the mformat~on on the protocol sheets of 373 o~ the patxents (:Fag 1) was tabulated and transferred to IBM c~xds The code was then ~evealed m order to analyze the data accordimg to the com- pounds All data were analyzed statastxcaHy ernploymg the cha-',quare test and p values ~ DOSKZN vt al. DOUBLE '501 ql PREMEDICATIO~ STUDY *l "'"= ~ ~"~ I-- iAia v ligHT OBED DRUG ~" ,t,.~.~ ITIME x s CAPSULE ~IVEX ?IME PRE IN~-dCTIOX ' OSE .... =~ L=.===,,==,=====~J ,, 4.SSE~S~E~Tt | SLEEPING DRU6 USUALLY TAKER? P. D.o AS.OG. R, EJ.RV NERVOUO EJ.OOMAL STABLE 3 TIME OF ONSET OF SLEEP ..... i ' ' 4 THYROTO~ICITY PRESENT PAST DEGREE ,LO fT..RE _ _. L p PRE INDUCTION DUES?IONS .~NAeS'rH~tlsr s OwN. mPRe.~sSiON ! - I A~ YOU CO~VO~T~SLr [~VE~ r-]No WAS TI~[ PATIENT r'-]COblFBRTASL E [] UNCOMFORTABLE = ARE YOU WORRIEO~ []~B []NO [] WOrrieD AF PREHENSIVE [] URTROUBLEO 3 ARE you 1ENBr [-lvE~ ~.o F-IE~ITED EJREL''O 4 ARE YOU UNUSUALLY HAPPY? [~YES ~]NO EJNA~I. EU.,OR,: [] BERE.~ S ARE YOU UNUSUALLY SLEEPY? ~']YE3 ~XO [~DR~WSY BLI'EPY E~JWlDE AWAt~E 6 IS YOU R STOMACH UPSET? [-]YES [~]NO [] TA~KATI VE [] QU IF.T 7 mo YOU VOM,T? I--]TE~ LIND NAU.EI~TED [] YES [] NO oo~ou FEEL tIrED7 [~v~s ~No ABLE 110 RAISE EYELIDS I"]YES [~]NO soo ~ou s~[ DOUaLE~ []YEa ~.o ABLE 10 HAND 6RIP FIRMLY ["]YES [~]NO |0 ANY COMPLAINTS? [~YE= ~]NO i ANAESTHETIST $ REPORT I t~ ADMISSION BLOOD PRESSURE PULSE REGPIRA1 ION PRE ,SEDATION VITAL SIGNS PULSE __ RESPIRA1 ION BLOOD PRESSURE , I PRE INDUCTION BLOOD PRESSURE PULSE REGPIRA't ION PUPIL SIZE__.__~..~ TIDAL VOLUME PRE SEDATION __ ML PRE I RDUCTII!IH -- ML I ' CHARTER OF INDUCTION ("-] SMOOT. ~SMOOTH Bur SLOW []D,EFICULT STOI'M 2 .EESS''ESE RE'ION TIME IN MINUTES BETWEEN |M ~ &INOUCTION ~UETIO~ AGEI~IT----- | A;~AESTHETI~T S ESTIMATIOR OF AOEO UACY OF PREMEDICATION --] ADED UATE ]INADEQUATE.... [~] EXCESSIVE POST OPERATION QUESTaONS i WHAT DO YOU REMLMBER HAPPENING JUST PRIOR TO YOUR OPERATION~ I [] I M INJECTION 2. [~TRIP TO OPERATING ROOM 3 [] MOVEMENT TO OPERATING TABLE . EJW''NOOET'ON 113PLEA'ANT II~UHP'EASANT E]'NO'F'ERENTO"U"~NO~" POST OPERATBVE REPORT 1 [] AMNESIA 2 [~]URINARY RETENTION (DID THE PATIENT HAVE TO BE CATHETERIZED WITHIN |0 HRS OF OPERATION? i~.o) 3 [~ SHIVERIRG 4 I[---(NVPOTE.SIO. [] AFTZ~ ,.OUCTlOR ~ POST INDUCTION 5 [] NAUSI A AND VOMITING POST-OPERATIVE 6 [~] DELA~ IN AWAKENING AFTER COMPLETION OF OPERATION (FROM RECOVERY ROGM NOTES) ~IINUTEB 7 REMAR~ 5__, ,,I ! L ' *COMPARISON OF SECOBARBITAL HYDROXYZINE Dobkln M D ..... Promethaz~ne a PLACEBO Allen B IMITIALS I Protoco~ for compdmg data and quesuonna~e F[CLmE i i 502 CANADIAN ANAESTttETISTS' SOCIETY JOURNAL TABLE I PATIENTS' ANSWERS TO DII~ECT QUESTIONS Promt] thazme, Hydroxyzme, Secobarbttal, Placebo, 91 pts 96 pts 90 pts 96 pts (%) (%) (%) (%) .... ' "i Discomfort 2 9 7 7 Apprehensmn 37 36 32 37 Exotement 33 35 25 24 Euphoria 5 2 5 4 Twedness 41 54 51 41 Sleepiness 33 41 41 41 Nausea 7 10 4 6 Vomited 1 1 2 1 Dlplopm 3 6 3 1 Complaints 22 14 17 28 I TABLE I i ANAESTHESIOLOGIST'S IMPRE%SION AS TO PATIENT'S STATE' Promethazme, Hydroxyzme, Secobarbltal, Placebo, 91 pts 91~D pts 90 pts 96 pts (%) (%) (%) Discomfort 8 g 5 6 Apprehensmn 38 42 27 35 Excitement 28 23 8 17 Euphoria 24 25 5 13 Sleepiness 39 57 60 59 Nausea 3 2 4 1 Talkatweness 6 12 8 9 Lid lag 1 3 1 7 Weakness 3 4 3 8 TABI}E III EFFECT OF PREMEDICATION ON VITA[ SIGNS BEFORE INDUCTION [,~ ........... [ , ,, Promethazme, Hydroxyzme, Secobarbltal, Placebo, 91 pts 96 pts 90 pts 98 pts (%) ,(%/ (%) (%) i Hypotenslon (> 20%) 6 I0 11 12 Hypertension (> 20%) 12 8 10 7 Tachycardm ( > 20%) 4 9 14 6 Bradycardm (>20%) 3 1 5 9 I TABLE IV I EFFECT OF PREMemCATION AND THm11'ENTAL INDUCTION ON BLO(m PRESSURE (>20% HYPOTENSION) DIURING FIRST 20 MINUTES ...
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